Sponsor
University of California, San Francisco
Status
Recruiting
ClinicalTrials.gov ID
For more information, see ClinicalTrials.gov NCT05028725
In the current protocol, we propose a study to evaluate a novel, combined esophageal sponge-methylation biomarker strategy for the early detection of esophageal squamous cell carcinoma (ESCC) as well as its precursor, esophageal squamous dysplasia (ESD). This strategy leverages the 'EsophaCap', a swallowable, retrievable sponge, with subsequent evaluation of the sample using a novel molecular biomarker assay. This biomarker assay evaluates methylation levels in select genes, which have been shown to differ significantly between ESCC cases and controls in pilot studies. Detection of methylation markers highly associated with ESCC could help identify patients with concurrent ESCC or at high risk of imminently developing this condition. If successful, this strategy could result in a paradigm shift for esophageal cancer control strategies in Tanzania and other high-incidence ESCC regions.
Intervention
Chromoendoscopy, EsoCAN assay, EsophaCap Sponge
Condition
Esophageal Squamous Cell Carcinoma, Esophageal Squamous Dysplasia
Investigators
Geoffrey Buckle, MD, MPH, Katherine Steitz, MD, MPH, Yona Ringo